The purpose of the study is to determine the amount of live virus that can be recovered from the nose of people who are vaccinated with the licensed live vaccine against H1N1, and to describe the immune response to vaccination.
By looking at the immune response before and after vaccine, we hope to understand the factors that determine the immune response and detailed shedding patterns of live novel H1N1 vaccine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
20
0.1mL per nares intranasally, second identical dose given 28 days after first vaccine
Vaccine Research Unit Room 3-5000
Rochester, New York, United States
Number of Participants Who Shed Virus
number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.
Time frame: 28 days post vaccine 1 and 28 days vaccine 2
Mean Difference Between Cycle Time and Detection Threshold
The mean difference was calculated by real-time polymerase chain reaction (PCR) on nasal wash samples. Cycle time is the cycle number at which the PCR reaction is positive with a range of 0-40 cycles. The detection threshold is 40 cycles.
Time frame: day 10 post vaccine 1
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